DK160033B - Agent for cleaning dentine surfaces - Google Patents

Description

x DK 1600S3 B

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a dentifrice (dentin) surfactant in the form of an aqueous solution containing benzalkonium chloride and a sequestering agent.

When treating teeth, especially caries-infested teeth, the tooth is usually drilled and the affected dentin removed. An amorphous lubricated layer is thereby produced, which adheres to the dentine surface due to electrostatic attraction. The smeared layer adhering to the dentine surface may contain microorganisms that can survive and grow under most types of fillings, and their degradation products can also destroy pulp. The amorphous lubricated layer should therefore be removed and the dentin surface treated with an antibacterial cleansing solution as a final step before filling or coating with a coating. This is necessary so that the risk of bacterial growth in the space close to the dentine surface is reduced, so as to improve the retention of cement in the material which insulates the dentine. These solutions should have no irritating effect on pulp when applied for approx. 1 minute. The well-known removal of the smeared layer of demineralizing solutions is a debatable practice. Although the application of acid to a dentin surface for 1 minute has no irritating effect on the pulp, the mouths of the dentine channels expand and open, and a uniform organic PC film will remain between the channels. Therefore, the dentin surface will be more difficult to dry and the adaptation to at least resinous materials will be reduced. A dentin surface with dilated dentine ducts may result in bacterial invasion of the dentine ducts if infection later occurs.

It has now been found that the lubricated layer can be effectively removed from the dentine surface by a cleaning agent, as described in the preamble, which is peculiar in that the solution further contains an ampholytic tin.

DK 160033 B

2 has the formula: Γ __ Ί in I +

! rr GH ^ I

5 ri i ^ il l ,, zero oh R ~ C-N "'L2rl4Ul' ·

XCH2Z II

Wherein R represents a fatty acid residue having 11-19 carbon atoms, R 1 represents C C and that the weight ratio of benzalkonium chloride to ampholytic surfactant is 9: 1 to 1: 9.

The sequestering agent included in the cleaner according to the invention is preferably an aminocarboxylic acid, and preferably the ratio of the amount of benzalkonium chloride to ampholytic surfactant to sequestering agent is 100: 1 to 1: 100.

Benzalkonium chloride is well known as a disinfectant, it is surfactant and has a dirt-releasing ability.

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The ampholytic surfactants e.g. of the dicarboxylated imidazolines type have been used as shampoos, but also in deodorizing agents with chlorhexidine. They have also been used as ampholytes in rust removers and in metal detergents.

The complexing agents, (sequestering agents), are used inter alia analytically to form complexes of metals, such as e.g. calcium.

The compounds of formula II are M as alkali metal, preferably sodium, but may represent lithium or potassium.

DK 160033 B

3

The ratio of benzalkonium chloride to the ampholytic surfactant is not critical, but even very small amounts of one component will produce a synergistic effect. Thus, 10-90 parts by weight of benzalkonium chloride 5 can be combined with 90-10 parts by weight of ampholytic surfactant. However, the ratio is preferably approx. 1: 1, e.g. 30-70 parts by weight of benzalkonium chloride and 70-30 parts by weight of ampholytic surfactant, preferably 40-60 parts by weight of benzalkonium chloride and 60-40 parts by weight of ampholytic surfactant.

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Typically, the dental cleanser consists of an aqueous solution in which the active ingredients are usually present in an amount of at least 0.1 g, preferably at least 1 g of these two compounds together per minute. 1 liter of solution. There is no upper limit, but no more than 50 g is usually used, preferably no more than 10 in total of these compounds per day. liter of solution. Further, the solution is usually buffered to the isoelectric point of the ampholytic surfactant. This is usually in the neutral range, i.e. pH approx. 6.5-7.5. It is also advantageous to add fluorine compounds such as e.g. sodium fluoride, potassium fluoride, and sodium monofluorophosphate. The amount of fluorine-containing compound can be up to 100 g per liter. per liter of solution, preferably a maximum of 50 g, e.g. 20-35 g per

25 liters of solution.

The complexing agent (the sequestering agent) is e.g. of the aminocarboxylic acid type, such as diethylene tri-amine penta acetic acid, nitrilo acetic acid; ethylene-diamino-tetraacetic acid is particularly suitable. Salts of these acids can also be used e.g. the sodium or potassium salts. The complexing agents are preferably used in an amount of at least 0.1 g / ml. liter of solution, e.g. The upper limit of the amount used is not critical, but is dependent on the time the agent acts on the tooth. Amounts of up to 15 g per liters of solution have been found to be well suited, but preferably 4

DK in 60033 B

turn 1-2 g per liter of solution.

It has been found that abrasive fractures that can adhere vigorously to an abrasive dentin surface due to electrostatic attraction can be easily removed with this complexing agent content. These abrasive fragments have previously been removed by surfactants, but in diamond abrasives, the abrasive fragments adhere so strongly that even 10 surfactant solutions do not produce satisfactory results.

It is well known to remove abrasive scraps with ethylenediaminetetraacetic acid, but this treatment of the dentine surface has adverse effects as it opens the mouths of the dentine channels and removes the surrounding dentin, the surface becomes wetter and more difficult to drain, and the treatment leaves a flat, thin film of organic compounds. which may interfere with the retention of 20 cement and filler material.

As the present dentin cleanser contains complexing agents, it can be used at such a concentration that there are no adverse effects and the dentin surface is satisfactorily cleaned even by diamond grinding. It has also been found that the complexing agent has a synergistic effect on the antibacterial properties of the present invention.

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Commonly used agents, such as other detergents, foaming agents, flavoring agents, etc. may be added to the present cleaning agent.

The subject agent comprises alkyldimethylbenzylammonium chloride (benzalkonium chloride). Its LDQ (lethal dose for 50% of the test animals) is 1173 mg / kg

DK 160033B

5 body weight of rats. Tolerance to mucous membranes has been investigated by once applying 0.1 ml of a 10% and 5% diluted sample to the rabbit eye's retina. With these high concentrates, irritation occurred in the form of 5 red staining.

The ampholytic surfactant is ionically balanced and its isoelectric point at pH is approx. 7.0. The cation and anion groups have equivalent strength, and the ampholytic surfactant is therefore miscible with all anionic, cationic and nonionic surfactants in all ratios, although it reacts more anionically in the alkaline region and more cationically in the acidic region. As a result, both the anionic and cationic groups are weak in the aforementioned 15 amphoteric surfactants, causing the compounds not to form insoluble salts. The full sodium salt is formed at pH 8-9 and the full acid salts are formed at pH 5-6.

The amphoteric surfactants in question are non-toxic. The minimum lethal dose by intraperitoneal injection is an average of 4.0 g / kg. A simple lethal dose for 50% of the test animals averages 10-15 g / kg. In addition, especially the coconut fat, lauric and capric acid derivatives have a clear detoxifying and reducing effect on other compounds, e.g. alcohol, emulsifiers, etc. Further, these amphoteric surfactants can be degraded biologically.

In the present purifier, benzalkonium chloride 30 and the ampholyte exhibit synergism.

The invention is further illustrated in the following examples.

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DK 16 0 O o 3B

EXAMPLE 1

Amphotert-2 "38% 0.30 g

Benzalkonium chloride 0.10 g 5 EDTA disodium salt 0.20 g buffer solution, pH 7.3 1.00 g distilled water in 100 ml EXAMPLE 2 10

Amphotert-2 ^ 38% 0.30 g

Benzalkonium chloride 0.10 g EDTA disodium salt 0.20 g sodium fluoride 1.00 g buffer solution, pH 7.3 1.00 g distilled water in 100 ml 1) 2- "cocoy1" -1 (sodium carboxylmethyl) -1-2- (carboxymethoxy) ethyl 2-imidazolinium hydroxide 20

For comparison purposes, teeth to be pulled out were grinded with a 200,000-300,000 rpm diamond drill bit. The treatment was carried out under water spray until a flat area of 1.2-2 2 25 mm dentin was exposed. After treatment, the patient was allowed to rinse the mouth, thereby contaminating the abraded surfaces with saliva. Subsequently, the surfaces were sprayed with copious amounts of water and dried for 5 seconds with compressed air prior to the experimental purge. The cleaning solution was applied to 30 by rubbing the surface for 5 seconds with a soaked cotton swab. The solution was then allowed to remain in contact with the abraded surface for 60 seconds before further wiping for 5 seconds. After a final drying with an air jet for 5 seconds, tooth 35 was pulled out. The extracted tooth was immediately placed in a 10% neutral buffered formalin solution. Using ordinary techniques, preparations were made of the abraded

DK 16 O CoZB

7 surfaces and examined in a scanning electron microscope.

The pictures were judged and gifted by well-trained professionals. Grade 0 denoted dentino surfaces completely covered with a smeared layer without anatomical details, such as e.g. dentin tube openings, while grade 3 denoted a surface with the tube openings open and slightly filled with abrasive pieces and with intertubular areas without any 10 signs of smeared layer.

For comparison, a known solution (Tubulicide $) was used

Blue Label) and a solution from Example 1.

The results are shown in the drawing, in which fig. 1 shows the result obtained with the known solution, and FIG. 2 shows the result obtained with the solution of Example 1.

The known solution contains chlorhexidine digluconate 0.1 g; dodecyldiaminoethylglycine (9% solution) 1.0 g distilled water per 100 g.

The purity of FIG. 1 was determined to grade 1; a thin amorphous lubricated layer covered the surface. The presence of pipe openings is indicated by small elevations. The magnification 30 is 1100 x.

The surface of FIG. 2 was rated Grade 3; the pipe openings are clearly visible; magnification 1100 x.

Thus, the present cleaner has the ability to remove most of the lubricated layer produced by grinding without opening too many pipe openings or removing

DK 160033 B

8 peritubular dentin.

Thus, the present cleaning agent of Example 1, which is the preferred solution, exerts an unexpected effect 5 by removing most of the lubricated layer without causing damage to the dentin surface itself.

10 15 20 25 30 35

Claims (4)

A dentin surface cleaner consisting of an aqueous solution containing benzalkonium chloride and a sequestering agent, characterized in that the solution further contains an ampholytic surfactant having the formula: 10 Γ r-tT in 1/2; 4- | ir ^ CH? Wherein R represents a fatty acid residue having an average of 11-19 carbon atoms, R * represents -Cl 2 .COOM, Z represents -COOM or Cl 2 .COOM and M represents a. alkali metal or hydrogen, the cleaning agent optionally containing caries inhibiting fluorine compound and a buffer and the weight ratio of benzalkonium chloride to ampholytic surfactant being 9: 1 to 1: 9. A cleaning agent according to claim 1, characterized in that M is an alkali metal as sodium. A cleaning agent according to any one of the preceding claims, characterized in that the sequestering agent is ethylenediaminetetraacetic acid or a salt thereof. 30 Purifier according to any one of claims 1-3, characterized in that the agent is an aqueous solution in which benzalkonium chloride and the ampholytic surfactant are present in an amount of 0.1-10 g per liter. 35 liters of solution and that the sequestering agent is present in an amount of 0.1-10 g / ml. liter of solution.